Clinical Data Interchange Standards Consortium (CDISC)
August 22, 2024
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The clinical study report is an essential part of the regulatory submission process. Its writing and finalization are important milestones. Company sponsors try their best to achieve this milestone as early as the availability of clinical study data (tables, listings, and figures [TLFs]) to meet the planned timelines of the drug development process. However, due to the uncertainty about the length of clinical study data, it becomes difficult to assess the exact time required to write and finalize a clinical study report. Therefore, to meet the planned timelines, the current industry practice is to split a clinical study report writing into two parts, i.e., shell writing (before the availability of clinical study data) and results writing (after the availability of clinical study data). The purpose of this blog is to enlighten the readers on clinical study report shell writing.
A shell is part of a clinical study report which is written after the completion of a clinical study at the site and before the availability of TLFs. Companies/ sponsors decide the limit of content that a shell contains, and it varies widely. This is communicated to the medical writer in a kickoff meeting, along with other requirements of the project. In the ICH E3 guideline sections, a shell can contain information in any of the two options given below:
This information is checked again and revised after the arrival of TLFs, which does not take much time.
As the shell includes methodological and administrative information of the clinical study, the useful documents for writing the shell include:
In the project kickoff meeting with the sponsor, the following questions should be clarified by the medical writer from the sponsor before beginning the shell writing:
Gaining the sponsor’s insight on the above questions will clarify expectations and deliveries between the sponsor and medical writer and help achieve the milestones on time.
Once the clinical study report shell has been locked, all the focus from the medical writer and sponsor’s team can be put on result writing after the arrival of TLFs.
Supporting Healthcare and Pharmaceutical Industries Across Internal, External, and Regulatory Communications. Delivering Top-Tier Support for Our Client’s Success.
Supporting Healthcare and Pharmaceutical Industries Across Internal, External, and Regulatory Communications. Delivering Top-Tier Support for Our Client’s Success.